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Trial record 43 of 257 for:    Anti-Infective Agents AND Antibiotics, Antitubercular AND broad

Antimicrobial Stewardship Through MRSA Diagnosis in Emergency Department (ED) Patients With Abscesses

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01523899
Recruitment Status : Completed
First Posted : February 1, 2012
Results First Posted : September 6, 2017
Last Update Posted : September 6, 2017
Johns Hopkins University
Information provided by (Responsible Party):
Larissa May, George Washington University

Brief Summary:
This study expands upon pilot data for feasibility since May 2011. The study aims to evaluate the effect of rapid test availability on use of targeted spectrum antibiotics for non-MRSA abscesses in ambulatory patients in the Emergency Department (ED). The multi-institutional study will assess the feasibility of providing the GeneXpert® MRSA/SA SSTI assay to the ED and evaluate the impact of delivering the test result to clinicians in real-time on patient management decisions regarding the use of antimicrobial agents. Patients are randomized to standard culture (control arm) or to the GeneXpert® assay plus standard culture.

Condition or disease Intervention/treatment Phase
Cutaneous Abscess Device: Xpert MRSA/SA SSTI Diagnostic Test: Standard culture Not Applicable

Detailed Description:

Our objective was to determine whether real-time availability of rapid molecular results of Staphylococcus aureus would impact emergency department clinician antimicrobial selection for adults with cutaneous abscesses.

We performed a prospective, randomized controlled trial in two urban emergency departments comparing a rapid molecular test with standard of care culture-based testing. Follow-up telephone calls were made at between 2 and 7 days, 1 month, and 3 months after discharge.

Patients at least 18 years old presenting with a chief complaint of abscess, cellulitis, or insect bite and receiving incision and drainage were eligible. Seven hundred seventy-eight people were assessed for eligibility and 252 met eligibility criteria.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 252 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: A Randomized Clinical Trial Comparing Use of Rapid Molecular Testing for Staphylococcus Aureus for Patients With Cutaneous Abscesses in the Emergency Department With Standard of Care.
Study Start Date : May 2011
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Abscess Antibiotics

Arm Intervention/treatment
Experimental: Xpert MRSA/SA SSTI
use of the Xpert MRSA/SSTI diagnostic assay
Device: Xpert MRSA/SA SSTI
Use of Xpert MRSA/SA SSTI assay

Active Comparator: Standard culture
performance of standard bacterial culture of abscess material
Diagnostic Test: Standard culture

Primary Outcome Measures :
  1. Number of Participants With Antibiotic Usage at the Time of the ED Visit [ Time Frame: Baseline ]
    Number of Participants with Antibiotic Usage at the time of the ED visit (narrow spectrum, broad spectrum, or none) will be recorded at the time of the ED visit

Secondary Outcome Measures :
  1. Participant Clinical Improvement Post-treatment at One Week [ Time Frame: 2 to 7 days ]
    clinical improvement (decreasing erythema, pain, swelling, drainage, and presence or absence of fever) will be documented at 2-7 day phone follow up and 1 and 3 months

  2. Clinical Outcome at One or Three Months [ Time Frame: 3 months ]
    Recurrence of abscess within a three month time period

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • adults 18 years or older with community onset abscess

Exclusion Criteria:

  • previous treatment for same abscess in past 14 days
  • postoperative infection
  • inability to provide informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01523899

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United States, District of Columbia
The George Washington University
Washington, D.C., District of Columbia, United States, 20037
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States
Sponsors and Collaborators
George Washington University
Johns Hopkins University
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Principal Investigator: Larissa S May, MD The George Washington University

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Larissa May, Assistant Professor of Emergency Medicine, George Washington University Identifier: NCT01523899     History of Changes
Other Study ID Numbers: 030927
First Posted: February 1, 2012    Key Record Dates
Results First Posted: September 6, 2017
Last Update Posted: September 6, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Larissa May, George Washington University:
cutaneous abscess
Additional relevant MeSH terms:
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Skin Diseases
Disease Attributes
Pathologic Processes